FDA UDI
In Commercial Distribution
🇺🇸 United States
LungVision System
DI: 07290017652085
·
Model: Core
·
BODY VISION MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LungVision System
- Primary DI
- 07290017652085
- Version / Model
- Core
- Catalog Number
- LV1055002
- Company Name
- BODY VISION MEDICAL LTD
- Labeler DUNS
- 600280073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-13
- Public Version
- 2
- Public Version Date
- 2022-05-27
- Public Version Status
- Update
- Public Device Record Key
- bf4bbb45-b783-4b57-a1b8-8173aac4fa13
Device Description
The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures. The mobile system cart is an optional unit to place the LUNGVISIONTM Main Unit and router, also used for storing all the system components: LV Board, Tablet, DVD reader, Keyboard, Mouse and cables.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58042 | Virtual bronchoscopic navigation PACS software | A software application intended to add specific image processing and/or analysis capabilities to a picture archiving and communication system (PACS) used for virtual bronchoscopic navigation (VBN). It is typically used by a bronchoscopist as a navigation system to help plan and provide guidance of a flexible bronchoscope to predefined target sites [also referred to as region of interest (ROI)] in the lung tissue of the tracheobronchial tree. It typically uses computed tomography (CT) scans in digital imaging and communications in medicine (DICOM) format. This software is typically installed in an off-the-shelf desktop or laptop computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017652085 | GS1 |